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Recurrence and Anal Fistula Patient Reported Outcomes Trial

NCT07477496 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-03-19

No results posted yet for this study

Summary

Perianal fistulas are a chronic anorectal condition associated with significant morbidity, including pain, persistent discharge, infection, and impaired continence, all of which can substantially affect patients' quality of life. Surgical management aims to eradicate the fistulous tract while preserving anal sphincter function and continence.

Despite numerous available surgical techniques, high-quality comparative evidence regarding optimal management remains limited. This prospective observational study aims to evaluate clinical outcomes, functional outcomes, and patient-reported quality of life following surgical treatment of perianal fistulas.

The study will collect both clinician-reported and patient-reported outcomes over a 12-month follow-up period. Outcomes of interest include fistula healing, recurrence, postoperative complications, continence status, symptom burden, and health-related quality of life. The findings are expected to provide real-world data that may inform clinical decision-making and contribute to improved patient-centered care.

Conditions

  • Anal Fistula Surgery
  • Anal Fistula
  • Perianal Fistula

Interventions

PROCEDURE

Perianal fistula surgical repair

Patients undergo the operative procedure that their treating colorectal surgeon selects as routine clinical care for a primary or recurrent perianal fistula. The operative approach may be a sphincter-dividing technique (e.g., fistulotomy or fistulectomy) or a sphincter-preserving technique (e.g., ligation of the intersphincteric fistula tract \[LIFT\], mucosal advancement flap, laser fistula treatment, fistula plug, autologous biologic product injection, or seton placement). No investigational devices or experimental protocols are used; the study records the specific technique, intra-operative details, and any adjunctive measures (draining seton, pre-operative imaging, antibiotics, etc.) to allow comparison of real-world outcomes across all accepted surgical modalities for perianal fistulas.

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-01-01
Completion
2030-01-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07477496 on ClinicalTrials.gov